FDA Further Delays Rulemaking on Medical Gases to November 2019

On May 22, 2019, the Trump Administration published its Spring 2019 Unified Agenda of Regulatory and Deregulatory Actions. The Unified Agenda provides an update on federal government regulatory activities, including rulemakings that are expected to be issued within the next 6-12 months. The Compressed Gas Association was very concerned to note that the U.S. Food and Drug Administration (FDA) has once again delayed the publication of its Notice of Proposed Rulemaking (NPRM), “Updated Regulations for Medical Gases,” until November 2019.

The Fall 2018 Unified Agenda projected an April 2019 publication date for this rulemaking. Now, the Spring 2019 Unified Agenda anticipates an additional 7-month delay. This runs directly contrary to direction from Congress. Within the Fiscal Year 2019 Consolidated Appropriations Act, the Joint Explanatory Statement gives clear instructions about the required timing for this rulemaking:

“The conferees support FDA’s commitment to complete a separate section of regulations for medical gas current good manufacturing practices. Therefore, the FDA shall issue final regulations required by the fiscal year 2017 Consolidated Appropriations Act no later than March 31, 2019.”

CGA will continue to engage with Congress on this matter, communicating our disappointment about the continuing delay, the fact that this projected rulemaking has been delayed well beyond the latest Congressional direction, and the importance of maintaining Congressional pressure in the fiscal year 2020 appropriations bill to get the rulemaking back on target.